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CTRI Number  CTRI/2018/09/015831 [Registered on: 25/09/2018] Trial Registered Prospectively
Last Modified On: 22/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To compare effects on blood pressure heart rate and shock duration of two drugs namely propofol and etomidate which are used to give anaesthesia during shock therapy to patients. 
Scientific Title of Study   COMPARISON OF EFFECT OF PROPOFOL AND ETOMIDATE ON HEMODYNAMIC PARAMETERS AND SEIZURE DURATION DURING ELECTROCONVULSIVE THERAPY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SHALAKA S PATIL 
Designation  Junior resident, department of anaesthesiology, LTMMC 
Affiliation  Lokamnya tilak municipal medical college and government hospital 
Address  Lokamnya tilak municipal medical college and government hospital,Sion Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7387790242  
Fax    
Email  shalaka0202@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr KAMLESH GOTIWALE  
Designation  Assistant professor, department of anaesthesiology, LTMMC AND LTMGH 
Affiliation  Lokamnya tilak municipal medical college and government hospital 
Address  Lokamnya tilak municipal medical college and government hospital,Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9967493254  
Fax    
Email  kgotiwale29@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr KAMLESH GOTIWALE  
Designation  Assistant professor, department of anaesthesiology, LTMMC AND LTMGH 
Affiliation  Lokamnya tilak municipal medical college and government hospital 
Address  Lokamnya tilak municipal medical college and government hospital,Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9967493254  
Fax    
Email  kgotiwale29@gmail.com  
 
Source of Monetary or Material Support  
Lokamnya tilak municipal medical college and government hospital 
 
Primary Sponsor  
Name  Dr SHALAKA S PATIL 
Address  Lokamnya tilak municipal medical college and government hospital,Sion Mumbai 400022 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SHALAKA S PATIL  ECT room psychiatric OPD LTMGH Sion Mumbai  Lokamnya tilak municipal medical college and government hospital Sion Mumbai 400022
Mumbai
MAHARASHTRA 		 7387790242

shalaka0202@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokamnya tilak municipal medical college and government hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA CLASS I AND II
 
 
ExclusionCriteria 
Details  1.OBESE(BMI>30)
2.COPD PATIENTS
3.KNOWN CASE OF EPILEPSY ON ANTICONVULSANT 4.THERAPY
5.DRUG ALLERGY TO PROPOFOL AND/OR ETOMIDATE
6.PREGNANT PATIENTS 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Alternation of Hemodynamics
1. Heart rate 2. Systolic blood pressure 3. Diastolic blood pressure 4. Mean arterial pressure 5. Saturation 		 Baseline
Before induction
After induction
1min after ECT
3min after ECT
5min after ECT
10min after ECT 
 
Secondary Outcome  
Outcome  TimePoints 
1.Compare recovery time
2.Adverse effects- arrythmia
Hypertension/hypotension
Tachycardia/bradycardia
Desaturation
Pain on injection 		 Baseline
Before induction
After induction
1min after ECT
3min after ECT
5min after ECT
10min after ECT 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/10/2018 
Date of Study Completion (India) 30/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/08/2019 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 Electroconvulsive therapy(ECT) is the mainstay of treatment for many psychiatric disorders. ECT requires Anaesthesia to control of hemodynamic changes and related complications along with primary requirements of amnesia and muscle relaxation. Anaesthesia has a significant influence on clinical efficacy and tolerability of ECT through impact on electrophysiological variables and seizure parameters. Therefore, its an on going process of searching drug of choice for ECT anaesthesia.
The study was conducted in 120 patients posted for ECT to compare drugs etomidate and propofol and their impact on various hemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and seizure duration and recovery time and advertise effects. 
The study concluded with separate advantages of both drugs over one another when study parameters were individualised.
Propofol has stable hemodynamic paramters and rapid recovery in comparison to etomidate whereas etomidate had longer duration of seizures and can provide better clinical efficacy than propofol. Etomidate however was associated with myoclonic jerks. Considering all the study parameters it is difficult to state the ideal drug for ECT. However, propofol seems to be a better anaesthetic agent for ECT than etomidate on considering the study parameters.
 
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